FDA.reportPublic FDA data

Emit® 2000 Valproic Acid

Primary DI
00842768023248
Brand
Emit® 2000 Valproic Acid
Company
Siemens Healthcare Diagnostics Inc.
Model
10445314
Catalog number
4G229
Device description
Emit ® 2000 Valproic Acid Assay labeled with the Beckman Coulter® name
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LEGENZYME IMMUNOASSAY, VALPROIC ACID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEGEnzyme Immunoassay, Valproic AcidClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011947000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011947000EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULSyva Co.2001-07-02LEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768023248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768023248008427680232488427680232480842768023248

GMDN Terms#

Term, Definition table
TermDefinition
Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug valproic acid in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-8994XX@XX.XX
+1(800)227-8994CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04015630915989Free Valproic Acid ControlsRoche Diagnostics GmbHLEG2021-06-11
07613336121610Valproic AcidRoche Diagnostics GmbHLEG2020-03-05
07613336157794Valproic AcidRoche Diagnostics GmbHLEG2020-03-05
00380740154158AlinityABBOTT LABORATORIESLEG2018-12-12
00630414596013Atellica CH VPASiemens Healthcare Diagnostics Inc.LEG2017-12-27
00884883001305CEDIA Valproic Acid II AssayMicrogenics CorporationLEG2016-09-30
05055273206456VPARANDOX LABORATORIES LIMITEDLEG2016-09-24
00842768000942Syva® Emit® 2000 Valproic Acid AssaySiemens Healthcare Diagnostics Inc.LEG2016-09-24
00842768005718Dimension® Flex® reagent cartridge VALPSiemens Healthcare Diagnostics Inc.LEG2016-09-24
00842768015526Dimension Vista® Flex® reagent cartridge VALPSiemens Healthcare Diagnostics Inc.LEG2016-09-24
00630414561950ADVIA® Chemistry VPA_2 Valproic Acid_2 ReagentsSiemens Healthcare Diagnostics Inc.LEG2016-09-24
00630414962290IMMULITE® 2000 Systems VAL Valproic AcidSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLEG2016-09-24
00630414964850IMMULITE®/IMMULITE® 1000 Systems VAL Valproic AcidSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLEG2016-09-24
04015630915958Valproic AcidRoche Diagnostics GmbHLEG2016-09-20
04015630997954Valproic Acid ONLINE TDM Valproic AcidRoche Diagnostics GmbHLEG2016-09-20
04015630998913Valproic AcidRoche Diagnostics GmbHLEG2016-09-20
04015630999385Valproic AcidRoche Diagnostics GmbHLEG2016-09-20
10758750006748VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LEG2016-08-26
15099590222178SynchronBeckman Coulter, Inc.LEG2016-08-24
00380740000332ARCHITECTABBOTT LABORATORIESLEG2016-06-06
00380740001810ARCHITECTABBOTT LABORATORIESLEG2016-06-06
00380740001827ARCHITECTABBOTT LABORATORIESLEG2016-06-06